Issue link: https://www.e-digitaleditions.com/i/1463386
Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs and results of clinical studies. 8 April 2022 Inhalation INDUSTRY NEWS Viatris and Kindeva receive US FDA approval for first generic of Symbicort ® Inhalation Aerosol P I T T S B U R G H , P E N N - SYLVANIA and ST. PAUL, MINNESOTA—Viatris and Kin- deva Drug Delivery announced that Mylan Pharmaceuticals, Inc., a Viatris subsidiary, has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Appli- cation (ANDA) for Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhala- tion Aerosol), the first approved generic version of AstraZene- ca's Symbicort ® .e drug/device combination product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be avail- able in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths. The complete indication for Breyna includes asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacer- bations for patients with COPD, including chronic bronchitis and/ or emphysema. According to the news release, the approval pres- ents an opportunity for Viatris to launch Breyna in 2022, as upcom- ing court proceedings develop. In December 2021, the US Court of Appeals for the Federal Circuit reversed an infringement judg- ment against Viatris and ordered the case remanded back to the US District Court for the Northern District of West Virginia for fur- ther proceedings. Rx Pack and Biocorp sign partnership to distribute Inspair™ ISSOIRE, FRANCE—Biocorp announced a new distribution agreement with Rx Pack that cov- ers commercialization of Inspair™, a smart sensor designed by Bio- corp that transforms pressurized metered dose inhalers (pMDIs) into connected devices. e agree- ment with RxPack, a 50:50 joint venture between Lindal Group and Coster Group, will grant exclusivity in several territories in South America, Eastern Europe, the Middle East and Southeast Asia. A news release from the companies stated that Inspair can provide an innovative and effective response to asthma and chronic obstructive pulmonary disease (COPD). It can directly affect compliance with treatment and strengthen the link between a patient and medical staff by providing real-time therapeutic monitoring. Inspair records daily inhalation data, monitors proper aerosol preparation, assesses inha- lation timing (hand-to-mouth coordination) and provides use- ful insights into the various stages of inhalation. continued on page 36